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Page 1: IandM Neuron 2 - usermanual.wiki · Overview The SmartLinx Neuron 2 is Capsule's point-of-care hardware platform for device connectivity. It is a flexible and scalable platform that

Copyright ©2014 Capsule Technologie. DC-NU2-IM-DOC

2.0August 22, 2014

SmartLinx Neuron 2 Hardware

Installation and Maintenance Guide

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Legal Notice

Copyright © 2014 Capsule Technologie. All rights reserved.

This product and related documentation are protected by copyright and distributed under licensing restricting their use, copying, distribution, and decompilation. No part of this product or related documentation may be reproduced in any form or by any means without prior written authorization of Capsule Technologie.

Trademarks

SmartLinx Administrator, SmartLinx Axon, SmartLinx Chart Xpress, SmartLinx Client, SmartLinx ESP, SmartLinx IQ, SmartLinx Medical Device Information System, SmartLinx Neuron, SmartLinx Vitals Plus, SmartLinx Vitals Stream, and related marks, images, and symbols are the exclusive properties of Capsule Technologie. Adobe Acrobat is a trademark of Adobe Systems, Inc.DISPATCH® is a registered trademark of Caltech Industries, Inc. Clorox® is a registered trademark and Clorox Healthcare™ is a trademark of the Clorox Company.Sani-Cloth® is a registered trademark of PDI, Inc. Corepoint Integration Engine is a trademark of Corepoint Health. Intel, Dual Core, and Pentium are trademarks or registered trademarks of Intel Corporation. Windows, Framework .NET, Message Queuing, MSMQ, Internet Explorer, XP, Hyper-V, Server 2003 and Server 2008 are trademarks or registered trademarks of Microsoft.

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Contents

Chapter 1: Introducing the SmartLinx Neuron 2 5Overview 5Intended Use 5About this document 6

Product designation in this document 6Purpose 6Audience 6Notes, cautions, warnings 6Related documents 7

Manufacturer’s Information 7Distribution and Service 8Table of abbreviations 8

Chapter 2: Setting up the SmartLinx Neuron 2 9What’s in this chapter 9Unpacking and inspecting the package contents 9

Contents of a product shipment 10Unpacking the cartons 10

Hardware installation prerequisites 11Installing the batteries in the SmartLinx Neuron 11

Installing the main battery in the SmartLinx Neuron 11Installing the optional extended battery in the SmartLinx Neuron 12

Deploying the SmartLinx Neuron 14Precautions for all deployments 14Considerations for wall-mounted deployments 14Mounting the SmartLinx Neuron on the wall 15Mounting the SmartLinx Neuron on a roll stand 15

Connecting the SmartLinx Neuron to the power supply 16Power requirements 16Connecting the SmartLinx Neuron to the power supply 16Before you use the SmartLinx Neuron for the first time 17

Chapter 3: Operating the SmartLinx Neuron 2 18Components on the SmartLinx Neuron 18Connectivity 20

Serial Ports 21USB Ports 21Ethernet Port 21

Powering on the SmartLinx Neuron 21Power on the SmartLinx Neuron 21Power Off the SmartLinx Neuron 22

Working with the SmartLinx Neuron touch screen 22Reading the status LED 22Working with the batteries 23

Battery Lifetime Terminology 23Battery Summary 23

3Table of Contents

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Charging the batteries 24Removing a battery 24Swapping a battery 24

Connecting the SmartLinx Neuron to the network 25Connecting a vital signs monitor to the SmartLinx Neuron 25

Before you connect 25Connecting the cables 26Connecting the devices 26For more on using the SmartLinx Neuron with the vital signs monitor 26

Chapter 4: Maintaining the SmartLinx Neuron 2 27Periodic cleaning and disinfection 27

Cleaning Precautions 28Periodic maintenance of the SmartLinx Neuron 28

Authorized Access 28Inspections 28Storing the SmartLinx Neuron 29

Maintenance of the SmartLinx Neuron batteries 29Cleaning 29Short-term maintenance 29Long-term storage and maintenance 29

Chapter 5: Technical Information 31Guidance and manufacturer’s declaration 31SmartLinx Neuron technical specifications 35Device Identification Module (DIM) technical specifications 36Regulatory Information 37

Explanation of Device and Packaging Symbols 37Safety and Regulatory Compliance 39

EN/IEC 39Federal Communications Commission 40CE Declaration 40Industry Canada statement 41RoHS and WEEE Compliance 42

Recycling and the Environment 42

Table of Contents

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Introducing the SmartLinx Neuron 2

Overview

The SmartLinx Neuron 2 is Capsule's point-of-care hardware platform for device connectivity. It is a flexible and scalable platform that you can configure to operate in various care areas of the hospital. In high acuity environments, such as the ICU, the SmartLinx Neuron 2 typically runs Capsule’s Vitals Stream Application to enable continuous collection of vital signs for one patient from multiple devices. In low acuity, non-critical care settings (such as med-surg), the SmartLinx Neuron 2 typically runs Capsule's Chart Xpress Application to enable the automatic collection, validation, and transmission of vital signs from multiple patients to the EMR directly from the point of care.

Note: Do not operate the SmartLinx Neuron 2 until after you read and understand these instructions. Pay particular attention to all warnings and cautions.

Note: For information about the administration of SmartLinx MDIS software, IT personnel should refer to the SmartLinx MDIS System Administrator’s Guide.

Note: To operate the SmartLinx Neuron 2, clinicians require training in the procedures described in the Clinical User’s Guide for SmartLinx Chart Xpress on Neuron and the Clinical User’s Guide for SmartLinx Vitals Stream on Neuron.

Note: To operate any medical device that connects to the SmartLinx Neuron 2, clinicians must be separately trained in the use of that device.

Intended Use

The intended use of the SmartLinx MDIS system is for data collection and clinical information management, either directly or through networks with independent bedside devices.

Capsule's hardware and software are not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices/information systems) to which it is connected. There is no other known contraindication for the use of the SmartLinx Neuron 2 system.

Caution: Do not modify the SmartLinx Neuron 2, cables, or any part of the SmartLinx MDIS software, or mount the device in any way other than instructed in Capsule documents. Any modification to the hardware or software can prevent proper functioning and cause damage to the connected medical device.

Introducing the SmartLinx Neuron 2 [Chapter 1] 5

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About this document

Product designation in this documentThe product described in this document is the “SmartLinx Neuron 2” (part number: DC-NU2-UMPC). For brevity and clarity, that product is referred to in the rest of this document as the “SmartLinx Neuron”. This means that all references to “SmartLinx Neuron” in this document shall be understood as applying to part number DC-NU2-UMPC.

Purpose This document provides:

• instructions for installing, mounting, and connecting the SmartLinx Neuron hardware• instructions for maintaining, cleaning, and storing the device and its accessories• details of technical characteristics and regulatory compliance of the device

Audience

The target audiences for this document are:

Notes, cautions, warningsWhere necessary, Capsule documents highlight any applicable warnings, cautions, and notes to avoid risk of injury to individuals or damage to equipment. There are three levels of information:

Note: Directions to clarify specific information to assist the user, and to avoid the risk of damage to the equipment described in this guide and/or any other equipment or goods, and/or cause environmental pollution.

Audience Description

Biomedical staff The biomedical staff ensures that the medical equipment is safe, functional, and properly configured for the clinical environment. They install, inspect, and maintain biomedical devices and support systems to adhere to medical standard guidelines.

Clinicians Clinicians are health care providers who interact with patients in a medical environment, such as a registered nurse, nurse technician, respiratory therapist, or anesthesiologist.

Warning: Indicates a hazard with a medium level of risk which, if not avoided, could result in death or serious injury.

Caution: Indicates a hazard with a low level of risk which, if not avoided, could result in minor or moderate injury or severe damage or malfunctioning of the equipment.

Introducing the SmartLinx Neuron 2 [Chapter 1]

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Related documentsCapsule provides the following additional documents for use with the SmartLinx Neuron.

Manufacturer’s Information

Document Description Audience

SmartLinx MDIS System Administrator's Guide (English only)

provides information on deployment scenarios and instructions on how to install, upgrade, and configure the SmartLinx Medical Device Information System software solution, including troubleshooting tips. Available from the:

• Help menu of the SmartLinx Neuron Manager • Capsule Customer Portal

Hospital IT staff

Clinical User's Guide for Vitals Stream on Neuron

provides information on how to use the Vitals Stream application, along with troubleshooting advice and hardware cleaning instructions.Available from the:

• Help menu of the SmartLinx Neuron Manager • Capsule Customer Portal• Help icon in the application

Clinicians

Clinical User's Guide for Chart Xpress on Neuron

provides information on how to use the Chart Xpress application, along with troubleshooting advice and hardware cleaning instructions.Available from the:

• Help menu of the SmartLinx Neuron Manager • Capsule Customer Portal• Help icon in the application

Clinicians

Capsule Technologie SAS9 Villa Pierre Ginier75018, Paris FrancePhone: (+33) 1 5334 1400

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Distribution and Service

For more information, or to order additional products (SmartLinx Neurons, or accessories including batteries, power cables, printed copies of documents), contact your reseller or Capsule directly:

Table of abbreviations

The table provides an alphabetical list of the main abbreviations used in this document.

USA EMEA & APAC

Capsule Tech, Inc.300 Brickstone Square, Suite 203Andover, MA 01810 USAPhone: 1-978-482-2300Toll Free: 1-800-260-9537

Capsule Technologie9 Villa Pierre Ginier75018, Paris FrancePhone: (+33) 1 5334 1400

Technical Support in North AmericaPhone: 1-800-260-9537 E-mail: [email protected]

Technical Support outside North AmericaPhone: (+33) 1 8417 1200E-mail: [email protected]

Abbreviation Meaning

AC Alternating Current

CE Conformité Européenne (= European Conformity)

CISPR Comité International Spécial des Perturbations Radioélectriques (= Special international committee on radio interference)

DIM Device ID Module

DTS DataCaptor Terminal Server

EN/IEC European Norm / International Electrotechnical Commission

FCC Federal Communications Commission

GB Gigabyte

LAN Local Area Network

LED Light Emitting Diode

MVP Mobile Vitals Plus

RoHS Restriction of the use of Hazardous Substances

VAC Voltage in Alternating Current

WEEE Waste Electrical and Electronic Equipment Directive

WLAN Wireless Local Area Network

WPA Wireless Protected Access

Introducing the SmartLinx Neuron 2 [Chapter 1]

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Setting up the SmartLinx Neuron 2

What’s in this chapter

Follow the instructions in this chapter to setup the SmartLinx Neuron. Deployment follows these steps, in this order:

• Unpacking and inspecting the package contents• Installing the batteries in the SmartLinx Neuron• Deploying the SmartLinx Neuron

• Mounting the SmartLinx Neuron on the wall• Mounting the SmartLinx Neuron on a roll stand

• Connecting the SmartLinx Neuron to the power supply• Before you use the SmartLinx Neuron for the first time

Note: This document does not describe the configuration of the SmartLinx Neuron on a local network. Refer to the SmartLinx MDIS System Administrator's Guide.

Unpacking and inspecting the package contents

Before you install the SmartLinx Neuron in a clinical setting, you must inspect and set it up according to instructions.

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Contents of a product shipment

The table describes the contents of a SmartLinx Neuron shipment.

Unpacking the cartons

Note: If the carton is broken, open, or damaged in any way, do not accept the shipment.

1. Turn the carton so that the arrow on the package is pointing up.

2. Cut the tape on the carton.

Item Shipment characteristics

SmartLinx Neuron In one carton, you find the SmartLinx Neuron itself, wrapped in plastic and sandwiched between two blocks of polyethylene foam. Each SmartLinx Neuron is shipped along with:

• Main batteryThe main battery is in position inside the SmartLinx Neuron, but the battery pins are not yet in contact with the battery socket on the SmartLinx Neuron, and the battery is not yet fixed in place.

• Power brickThe power brick is shipped wrapped in plastic.

• Screws and washersIncluded in a plastic bag, the shipment contains screws for attaching the SmartLinx Neuron to a mounting bracket, depending on the deployment selected:

- Four M4 Phillips-head screws of 6 mm, with associated washers - Four M4 Phillips-head screws of 8 mm, with associated washers

Power Cable The electrical cable that is used to connect the SmartLinx Neuron power brick to the electrical mains outlet is shipped in a separate carton from the SmartLinx Neuron. This cable is always adapted to local requirements.

Extended battery (optional)

If ordered, extended batteries are shipped in a separate carton, where possible, the same carton as for the cables. Each extended battery is packed in its own unit box.

This document Printed copies of this SmartLinx Neuron 2 Hardware Installation and Maintenance Guide are shipped separately, in the same carton as the cables, where possible. The number of copies depends on the number of SmartLinx Neurons in the shipment.

Additional elements Depending on the contents of your order, other connectivity elements such as serial cables, patch cables, and DIMs, could be present in the shipment. If yes, these are typically shipped in the same carton as for the cables.

Caution: Be careful to cut only the tape and not, for example, the SmartLinx Neuron.

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3. Take each item out of the carton. 4. Check all items against the packing list, and against the list in Contents of a product shipment

above.5. Remove the packing material and examine each item for any signs of shipping damage. 6. Save all packing materials, the invoice and the bill of lading. You will require them if you need to

process a claim with the carrier.

Hardware installation prerequisites

You need the following tools (not included) to install the SmartLinx Neuron:

• one cruciform-tip screwdriver• one flat (that is, straight) screwdriver• one Phillips-head PH0 screwdriverIn addition, depending on how you intend to mount the SmartLinx Neuron, you could require certain hardware:

• If you select to deploy the SmartLinx Neuron on a roll stand, you must source a roll stand pole extension with VESA 75 or VESA 100 interface suitable for the model of your roll stand. Contact your roll stand manufacturer for options.

• If you select to deploy the SmartLinx Neuron on a wall-mount, then you require a mounting solution that is VESA 75/100-compatible.

Installing the batteries in the SmartLinx Neuron

Installing the main battery in the SmartLinx Neuron The SmartLinx Neuron is shipped with the main battery in position but not yet fixed in place.

1. Push the main battery towards its connection port.

2. Use a screwdriver or other tool to screw in the two screws that hold the main battery in place. 3. Tighten the screws until the battery is connected to its pins. Do not overtighten.

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Installing the optional extended battery in the SmartLinx Neuron 1. Turn the SmartLinx Neuron so that the screen is facing away from you.2. Use a screwdriver to unscrew the screw that holds the extended battery faceplate in position.3. Push the loose faceplate to the left, then lift the faceplate away from the SmartLinx Neuron.

4. Position the extended battery at the same point where you lifted the faceplate. Because of the arrangement of the pins, you cannot position the extended battery incorrectly.

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5. Slide the extended battery to the right. Continue sliding until the left side of the extended battery is flush with the left side of the extended battery slot.

6. Push the locking button on the extended battery to the down position.

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Deploying the SmartLinx Neuron

In typical deployments of the SmartLinx Neuron, you can mount it on the wall, or mount it on a roll stand or other mobile configuration using commercially available, compatible mounting solutions (not supplied by Capsule).

It is your responsibility to select an appropriate mounting solution and ensure that it is safely setup.

Note: For compliance with EN/IEC 60601-1, the SmartLinx Neuron is not classified as a portable device. Instead, the SmartLinx Neuron must be deployed as one of:- Mobile device - Fixed device

Precautions for all deployments

Considerations for wall-mounted deploymentsWhen you are deciding where to place the SmartLinx Neuron at the point of care, Capsule recommends that you take account of the following considerations.

• Mount the SmartLinx Neuron near the head of the bed or on the head wall in the patient room.• To allow clinicians easy access to the SmartLinx Neuron touch screen, mount the SmartLinx Neuron

no more than 1.5 meters (5 feet) or less than 1 meter (3 feet, 3 inches) from the ground.• If there are medical devices connected to the ports on the SmartLinx Neuron, position the SmartLinx

Neuron on the same side of the bed as those devices. • Make sure that you take account of the length of the cables required to connect the SmartLinx

Neuron and the medical devices.

Warning: Fire and explosion hazard. Do not operate the SmartLinx Neuron in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment.

Caution:• Do not place the SmartLinx Neuron inside furniture or inside any enclosed space. This could

prevent correct cooling of the device and interfere with radio communications.• Operate the SmartLinx Neuron only within these environmental conditions:

- Temperature: +10°C to +40°C (+32°F to °+104°F)- Atmospheric pressure: Atmospheric pressure: 700 hPa to 1060 hPa- Altitude: -100 meters to +2000 meters (-328 feet to +6560 feet)- Humidity: 10% to 95% RH non-condensing

• Do not stack the SmartLinx Neuron or place it next to other equipment. If you do, then check it for normal operation running its usual configuration.

• In semi-private rooms, connectors must be placed or labeled so that they clearly indicate the bed for which they collect data.

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Mounting the SmartLinx Neuron on the wall

Attach the SmartLinx Neuron to your selected VESA 75/100 wall-mounted solution. Refer to the instructions from the solution manufacturer.

Mounting the SmartLinx Neuron on a roll stand1. Mount the SmartLinx Neuron to the roll stand. Refer to the manufacturer’s instructions for the

roll stand as required. 2. Select the set of screws (delivered with your SmartLinx Neuron) whose length corresponds to

the depth of the screw holes on your VESA75/100-compatible mounting plate. Alternatively, use the screws delivered with your roll stand pole extension to mount the SmartLinx Neuron.

Caution: For SmartLinx Neurons that are installed above the patient, take adequate precautions to prevent them from falling on the patient.

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Connecting the SmartLinx Neuron to the power supply

Once deployed, on a wall or roll stand for example, you can connect the SmartLinx Neuron to the power supply.

Power requirementsThe SmartLinx Neuron is designed to use the IEC 60601-1-compliant, external DC power supply and power cables that are provided with the SmartLinx Neuron. For precise information, refer to the Technical Information in chapter 5 of this document.

Connecting the SmartLinx Neuron to the power supply1. The power brick that was shipped with your SmartLinx Neuron has a power cable on one end,

and an open plug on the other end. Plug that power cable into the SmartLinx Neuron at the DC-in power connector (as illustrated).

2. Tighten the locking mechanism on the DC-in power connector to lock the power plug in place.3. Plug the power cable that was shipped with your SmartLinx Neuron into the open plug on the

power brick.

4. Plug the other end of that power cable into an grounded electrical outlet (generally 3-prongs).

Cautions:• Always use the hospital-grade, AC power cable delivered with the product to connect the

SmartLinx Neuron to an AC power source. Do not, under any circumstances, use any other cable than the one provided, even to provide extra cable length. The use of any other cable can result in increased emissions or decreased immunity of the device with regards to electromagnetic interference.

• Do not connect the SmartLinx Neuron to an AC outlet that is controlled with a switch or dimmer.• Do not, under any circumstances, remove the grounding conductor from the power plug.• Do not use extension cords or adapters of any type.• The power cable, supply, and plug must remain intact and undamaged.• The power plug must remain accessible to unplug the device from the power supply mains if

necessary.

Caution: For safety, cables are designed to prevent inadvertent disconnection if someone accidentally pulls on them. However, make sure that you route cables so that they do not present a tripping hazard.

Warning: You must only connect the SmartLinx Neuron’s power brick to an appropriate power source. To avoid risk of electric shock, use a grounded (3-prong) electrical power outlet.

Setting up the SmartLinx Neuron 2 [Chapter 2]

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Before you use the SmartLinx Neuron for the first timeFor all deployments, before you use the SmartLinx Neuron for the first time, you must completely charge its battery.

1. Set up the SmartLinx Neuron as described in this chapter:

• install the main battery

• install the extended battery, if you use one

• connect the SmartLinx Neuron to the electrical mains2. The battery/ies start to charge as soon as you plug the SmartLinx Neuron into the electrical

mains. Allow the main battery to charge for about two hours. If you have installed both the main battery and the optional extended battery, allow the two batteries to charge for about six hours.

For a fuller description of the batteries, and the charging / discharging process, refer to “Working with the batteries” on page 23.

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Operating the SmartLinx Neuron 2

Components on the SmartLinx Neuron

Legends on the drawingsIn the legend for the drawings that follow:

• Individual components keep the same numbers on each drawing. For example, the USB ports on the bottom of the SmartLinx Neuron are shown with the number . When you see the number , you know that it represents only these ports.

• Colors have meaning. A blue circle indicates a medical-grade connector. A yellow circle indicates network connection (Ethernet). All other components are indicated with red circles.

View from the front

6 6

Light sensor

Touch screen

Status LED

RFID badging area

Serial ports

USB ports

1

2

3

4

5

6

1

2

3

5 6

4

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View from the bottom

3/4 view from the back

5 6

7 8 10 9

Serial ports (4) - front-accessible

USB ports (2) - front-accessible

USB ports (2) - rear-accessible

Serial port (1) - rear-accessible

Ethernet connection

DC power-in connector

5

6

7

8

9

10

5 6

7

8

10

9

Serial ports (4) - front-accessible

USB ports (2) - front-accessible

USB ports (2) - rear-accessible

Serial port (1) - rear-accessible

Ethernet connection

DC power-in connector

5

6

7

8

9

10

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View from the back

Views from the side

Connectivity

The ports on the SmartLinx Neuron are used to connect medical or other devices. A blue line on these ports indicates a medical-grade connection port. A yellow line indicates the Ethernet connection port. The tables describe the ports.

11

13

12 12

12 12

15

Extended battery emplacement

Mounting plate screwholes (VESA 75/100 configuration)

Main battery

Covered USB port

Aeration vents

Speaker

11

12

13

14

15

16

14

16

17 13 14

Main battery

Covered USB port

Anti-theft slot

13

14

17

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Serial Ports

USB Ports

Ethernet Port

Powering on the SmartLinx Neuron

For information on connecting the SmartLinx Neuron to the power supply, refer to “Connecting the SmartLinx Neuron to the power supply” on page 16.

Power on the SmartLinx NeuronFor manual operation, press the Power On/Off button, shown at position on this illustration of the top view of a SmartLinx Neuron:

Location Characteristics Number Purpose

Front Galvanic isolated RS-232 with RJ45 connector

4 Used to connect medical devices with serial interfaces

Rear Galvanic isolated RS-232 with RJ50 connector

1 Used to connect medical devices with serial interfaces

Location Characteristics Number Purpose

Front Galvanic isolated, Type A USB 2.0 full-speed

2 Used to connect medical devices with USB interfaces

Rear Galvanic non-isolated, Type A USB 2.0 high-speed

2 Used to connect external USB, non-medical devices such as barcode scanners

Side (left) Galvanic non-isolated, Type A USB 2.0 high-speed

1 Additional USB, non-medical device connection

Location Characteristics Number Purpose

Back RJ45 connector 1 Used to connect to the hospital-internal, wired network (Ethernet)

A

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Power Off the SmartLinx NeuronTo power off the SmartLinx Neuron, press the On/Off button again.

If the SmartLinx Neuron does not shut down properly for any reason, you can do a hard shutdown. Press and hold the power button for four seconds.

Working with the SmartLinx Neuron touch screen

The SmartLinx Neuron screen is a 10.1-inch (25.6-centimeter) touch screen. It is antiglare treated, and readable from multiple angles.

Screen brightness adjusts automatically to the level of ambient light, dimming or brightening in parallel with the current level of luminosity in the room. If the screen goes completely dark, the SmartLinx Neuron is said to be in ‘sleep’ mode, and you can wake it up by touching the screen.

Reading the status LED

The SmartLinx Neuron provides a single LED, located on the front of the device below the screen.

LED SmartLinx Neuron Status

Off SmartLinx Neuron is not running.

Blue - Blinking SmartLinx Neuron is booting.

Blue SmartLinx Neuron has finished booting, and is EMR-connected.

Red SmartLinx Neuron has finished booting, and is not EMR-connected.

A Power On/Off button

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Working with the batteries

For instructions on installing the main battery, and the optional extended battery, refer to “Installing the batteries in the SmartLinx Neuron” on page 11.

Note: Before you use each SmartLinx Neuron for the first time, you must fully charge its battery/ies, as described in “Before you use the SmartLinx Neuron for the first time” on page 17.

Battery Lifetime TerminologyWhen describing the SmartLinx Neuron, the following terms are used:

• Battery autonomy refers to the amount of time that the SmartLinx Neuron can remain fully functional in case of a disconnect from the electrical mains.

• Battery life span refers to the total time that the battery lasts before you must replace it.

Battery Summary

Warning: Defective batteries can damage the SmartLinx Neuron. If the battery shows any signs of damage or cracking, it must be replaced immediately and only with a battery approved by Capsule.

Warning: Improper disposal of batteries may create an explosion or contamination hazard. Never dispose of batteries in refuse containers. Always recycle batteries according to local regulations.

Characteristic Main Battery Extended Battery

Autonomy 150 minutes (2 hours 30 minutes) of functional operation when unplugged from AC mains, with a new, fully-charged battery

240 minutes (4 hours) of functional operation when unplugged from AC mains, with a new, fully-charged battery

When used together, the two batteries together provide about 360 minutes (6 hours) of autonomy.

Charging time 120 minutes (2 hours) 240 minutes (4 hours) for the extended battery alone360 minutes (6 hours) to charge both batteries

Charging First charged / Last discharged Last charged / First discharged

Life span After 500 complete charging cycles, remaining capacity is about 80%.

After 500 complete charging cycles, remaining capacity is about 80%.

Shelf-life 3 months 3 months

Swapping By biomed user - requires no tools other than a screwdriver

By clinical user - requires no tools

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Charging the batteriesTo charge the batteries, plug the cable from the SmartLinx Neuron power brick into the AC power mains (wall socket).

To monitor the batteries during the charging process, check the battery information displayed on the screen, and described in the Capsule document, Clinical User’s Guide for the Chart Xpress application.

Removing a battery

Removing the main batteryRefer to the illustrations for Installing the main battery in the SmartLinx Neuron on page 11.

1. Use a screwdriver or similar tool to unscrew the two screws that hold the battery in place.2. Pull the battery gently away from the SmartLinx Neuron to disconnect the battery from the pins.3. Remove the battery.

Removing the extended batteryRefer to the illustrations for Installing the optional extended battery in the SmartLinx Neuron on page 12.

1. To release the extended battery, push the locking button to the up position. 2. Slide the extended battery to the left. 3. Lift the battery out and away. 4. If desired, and if you have retained the faceplate, you can replace the faceplate on the empty

battery slot. Use a screwdriver and the screw that you removed when you installed the extended battery.

Swapping a batteryTo swap a charged battery in place of a discharged battery, or to swap a new replacement battery for a depleted battery:

1. Remove the battery, as described above under Removing a battery.2. Install the new battery, as described in “Installing the batteries in the SmartLinx Neuron” on

page 11.

Caution: Batteries must be replaced only by qualified, certificated engineers.

Warning: To avoid the possibility of an explosion, use only batteries supplied by Capsule or a Capsule-approved reseller. If you use any other battery, you risk an explosion.

Caution: Before you remove a battery from a SmartLinx Neuron which is powered on, make sure that it continues to receive power, either from the electrical mains, or from at least one charged battery that is installed in the SmartLinx Neuron.

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Connecting the SmartLinx Neuron to the network

Connecting to a wired network1. Plug one end of the LAN cable into the Ethernet connector, located on the rear panel of the

SmartLinx Neuron, and marked with a yellow line. In the illustrations, on page 19 for example, this connector is labeled .

2. Plug the other end of the same cable into the network socket (typically on the wall).

Connecting to a wireless networkNo special procedures are required on the SmartLinx Neuron for wireless connection. However, each SmartLinx Neuron must be configured in the SmartLinx Neuron Manager to use the wireless network. Refer to the “SmartLinx MDIS System Administrator’s Guide” for more.

Checking the wired connectionOn the Ethernet jack, there are two small LEDs. When you plug in the Ethernet connection cable, you can check the connection through the behavior of these LEDs:

Checking the wireless connectionYou cannot check the wireless connection using SmartLinx Neuron hardware components. You must use the network connection information displayed on the screen, and described in the Clinical User’s Guide for the Chart Xpress application or the Vitals Stream application.

Connecting a vital signs monitor to the SmartLinx Neuron

Before you connectBefore you connect a vital signs monitor to the SmartLinx Neuron, you must program its Capsule Device ID Module (DIM). A Capsule DIM is required for all devices connected to the SmartLinx Neuron. For information on how to program a Capsule DIM, refer to the “SmartLinx MDIS System Administrator’s Guide”. The Device ID Module (DIM) supports plug-and-play connectivity. Its automatic device identification feature allows users to connect and re-connect any biomedical device to the SmartLinx Neuron with ease. The separate DIM attached to each device through a cable assembly allows the SmartLinx Neuron to:

LEDs State Meaning

Link/Act Off The SmartLinx Neuron is not connected to the LAN

Blinking Network activity

On Link is active

10/100/1000 Off Connected to the LAN at 10 MB speed, or Not connected

Green Connected at 100 MB speed

Orange Connected at 1000 MB speed

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• automatically identify the attached device• initialize the appropriate Data Device Interface (DDI)• detect when the device is disconnected and re-connected

Connecting the cables1. Attach the device cable from the device to the DIM (Device ID Module).2. Attach the DIM patch cable to the RJ45-end of the DIM.

Connecting the devices1. Attach the RJ45-end of the cable assembly into one of the ports of the SmartLinx Neuron. Refer

to the description of “Connectivity” on page 20 for the set of available ports. 2. Connect the other end of the cable assembly to the back of the vital signs monitor.3. Tighten the thumb screws and secure the assembly behind the monitor.

For more on using the SmartLinx Neuron with the vital signs monitorThis manual does not describe the use of the SmartLinx Neuron with vital signs monitors. Instead, refer to the following documents:

Caution: If you use unapproved cables to connect medical devices to the SmartLinx Neuron, you could cause damage to or malfunctioning of the medical device.

Device cable DIM DIM patch cable

Subject Where to look

How to configure SmartLinx Neuron SmartLinx MDIS System Administrator’s Guide

How to operate SmartLinx Neuron Neuron Vitals Stream Application Clinical User’s Guide

Neuron Chart Xpress Application Clinical User’s Guide

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Maintaining the SmartLinx Neuron 2

Capsule recommends that you carry out regular maintenance activities as described in this guide to ensure correct operation of the device.

Periodic cleaning and disinfection

Periodically clean and disinfect the elements in the SmartLinx Neuron, including cables and batteries, by wiping the outer case with a lint-free cloth, lightly moistened with warm water and a mild, non-abrasive cleaning solution containing any of the compatible cleaning agents below (follow the manufacturer’s guidelines):

Warning: Electric shock hazard. Do not open the SmartLinx Neuron or attempt repairs. The SmartLinx Neuron has no user-serviceable internal parts. Only perform routine cleaning and maintenance procedures specifically described in this manual. Inspection and servicing of internal parts must only be performed by qualified service personnel.

Caution: When cleaning or disinfecting the SmartLinx Neuron, batteries, and cables, you must power off the device first. However, you can use standard computer screen solution to wipe down the SmartLinx Neuron touch screen (for example, to remove fingerprints) during normal operation, while it is powered on.

• 70% isopropyl alcohol • 10% bleach solution

• CaviCide® • Clorox® Disinfecting Wipes

• Clorox Healthcare™ Bleach Germicidal Cleaner

• Sani-Cloth®, Sani-Cloth® Plus, Super Sani-Cloth®, Sani-Cloth® HB, Sani-Cloth® Bleach Wipe

• ANIOSURF Premium, Bacteranios SF, SURFA’SAFE, WIP’ANIOS

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Cleaning Precautions

Periodic maintenance of the SmartLinx Neuron

Authorized AccessCertain components on the SmartLinx Neuron are only accessible to Capsule technical support personnel. These elements are held in place using special screws referred to as “hexalobular internal”.

However, other components on the SmartLinx Neuron, such as the main battery, can be removed by biomed staff, for purposes of maintenance or cleaning, for example. These elements are held in place using Philips screws.

Inspections

Once per year, carry out an inspection of:• the power cable• the power brick

Look for any visible or other damage, overheating, or corrosion. A damaged power cable or power brick can affect the operation of the SmartLinx Neuron. Replace damaged components with new components.

Caution:• Since the SmartLinx Neuron is not completely watertight:

- Do not spray cleaning liquid or foam on the SmartLinx Neuron, or submerge or soak it for cleaning.

- Never spray or squirt any type of liquid directly on the SmartLinx Neuron; spray the liquid, gel, or foam on a cloth and then use that cloth to rub on the device.

- Do not spill liquids on or around the unit.- Do not expose the power cable or power brick to liquid.- Make sure that the cover on the USB port is securely fastened.

• Do not use any other agent than those listed. (Contact Capsule for assistance if your cleaning agent is not on the list.)

• Do not use harsh solvents.• Do not clean, disinfect, or sterilize any part of the system by autoclaving or with the use of ethylene

oxide gas (gas sterilization).• Do not touch, press, or rub the display panel with abrasive cleaning compounds, instruments,

brushes or rough-surface materials.

Caution: Power off the SmartLinx Neuron before you inspect the power cable and power brick.

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Storing the SmartLinx NeuronIf the SmartLinx Neuron is not in use, make sure that you respect its storage conditions:

• Temperature: -20°C to +60°C (-4°F to +140°F)• Humidity: 0% to 95% RH non-condensing• Atmospheric pressure: 500 hPa to 1060 hPa

Maintenance of the SmartLinx Neuron batteries

CleaningWhen cleaning the SmartLinx Neuron batteries, apply the cleaning procedures and precautions described above under “Periodic cleaning and disinfection”.

Short-term maintenanceFor daily usage purposes, it is recommended that you keep the batteries in charge mode; that is, keep the batteries installed in the SmartLinx Neuron, and keep the SmartLinx Neuron connected to the electrical mains.

Long-term storage and maintenance

Shelf life of the batteriesBoth the main and the extended batteries for SmartLinx Neuron have a shelf life of three months. This limit applies to batteries that are not in use (that is, if they are not either in the process of charging, or being used to supply power to the SmartLinx Neuron).

If the battery fully discharges, during storage for example, then you must replace it.

Storing the batteriesIf the SmartLinx Neuron is not in use for an extended period of time, we recommend that you:

1. Charge the battery completely.2. Remove the fully charged battery from the SmartLinx Neuron (refer to “Removing a battery” on

page 24).3. To maximize the battery life span, make sure that you store the battery within the

recommended parameters:• Temperature: -20°C to +60°C (-4°F to +140°F)• Humidity: 0% to 95% RH non-condensing• Atmospheric pressure: 500 hPa to 1060 hPa

• Store the battery and the SmartLinx Neuron separately.

Caution: Both the main battery and the extended battery have shelf lives of three months from the date of manufacture. You must install a newly received battery in a SmartLinx Neuron, and fully charge the battery within three months of receipt. Refer to the SmartLinx Neuron packaging for the battery expiration date.

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Technical Information

Guidance and manufacturer’s declaration

Electromagnetic EffectsThe SmartLinx Neuron radiates and consumes radio frequency energy. It has been designed and evaluated to comply with the emission and immunity requirements of EN/IEC 60601-1-2, but electromagnetic interference may occur if not installed correctly and used in accordance with the instructions in this manual. Refer to the Tables in this chapter for detailed information regarding declaration and guidance related to emission, immunity, and separation distances.

Electromagnetic EmissionsThe SmartLinx Neuron is intended for use in the electromagnetic environment specified below. The customer or the user of the SmartLinx Neuron should make sure that it is used in such an environment.

Note: UT is the AC mains voltage prior to application of the test level.

Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)The SmartLinx Neuron is intended for use in the electromagnetic environment specified below. The

Caution:• Portable and mobile radio frequency devices, such as mobile phones, can impact the correct

functioning of this device and should not be used in close proximity of this device.• Use of accessories, power adapters and cables other than those specified may result in

increased emission and/or decreased immunity of the SmartLinx Neuron.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1 The SmartLinx Neuron uses RF energy only for its internal function; its RF emissions are therefore very low and are not likely to cause any interference to nearby electronic equipment

RF emissions CISPR 11 Class A Class A: The SmartLinx Neuron is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

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customer or the user of the SmartLinx Neuron should ensure that it is used in such an environment.

Immunity Test IEC 60601 test level Compliance level

Electromagnetic environment - Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. ±8 kV air ±8 kV air

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV for input/output Lines

±1 kV for input/output Lines

Surge IEC 61000-4-5 ±1 kV line(s) to line(s)

±1 kV line(s) to line(s)

Mains power quality should be that of a typical commercial or hospital environment.

±2 kV line(s) to earth

±2 kV line(s) to earth

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle

>95% voltage dips in UT for 0.5 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SmartLinx Neuron requires continued operation during power mains interruptions, it is recommended that the SmartLinx Neuron be powered from an uninterruptible power supply.

40% UT (60% dip in UT) for 5 cycles

60% voltage dips in UT for 5 cycles

70% UT (30% dip in UT) for 25 cycles

30% voltage dips in UT for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

>95% voltage interruption in UT for 5 seconds

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital environment.

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Electromagnetic Immunity (RF Conducted and Radiated)The SmartLinx Neuron is intended for use in the electromagnetic environment specified in the table. The customer or the user of the SmartLinx Neuron should make sure that it is used in such an environment.

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be pre-dicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans-mitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SmartLinx Neuron is used exceeds the applicable RF compliance level above, the SmartLinx Neuron should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SmartLinx Neuron 2.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Immunity Test

IEC 60601 test level

Compliance level Electromagnetic environment - Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 V Portable and mobile RF communications equipment should be used no closer to any part of the SmartLinx Neuron, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with this symbol:

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

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Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the SmartLinx NeuronThe SmartLinx Neuron is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SmartLinx Neuron can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SmartLinx Neuron as recommended below, according to the maximum output power of the communications equipment.

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Rated maximum output power of transmitter (W)

Separation distance in meters according to frequency of transmitter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

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SmartLinx Neuron technical specifications

SmartLinx Neuron Part Number: DC-NU2-UMPC

Dimensions Width: 265 mm (10.4 inches)Height: 210 mm (8.3 inches)Depth: 45 mm (1.8 inches)

Weight 2.0 kg (2.3 kg with batteries)

Mounting options VESA 75/100 standard mounting bracket

Electrical ratings 20 V DC, 3.25 A max

External power supply 100-240 V AC, 2.0-1.0 A, 50-60 Hz, 65 W max

Battery Main: Lithium-lon Battery Pack 3S1P 2600 mAhExtended: Lithium-lon Battery Pack 3S2P 5200 mAh

Protection against electric shock Class II

Protection against ingress of water

IPX0Non-protected according to EN/IEC 60529

Suitability for use in oxygen-rich environments

No suitable

Mode of operation Continuous

Display size 10.1 inch (25.6 centimeter), resistive touch screen, resolution 1024x600

Display brightness 375 cd/m²

Contrast 400:1

Memory 2 GB

Storage 16 GB SSD

Network connectivity 10/100/1000 base-T LANWLAN IEEE 802.11 a/b/g/n

WLAN security WPA & WPA2 personal, WPA & WPA2 enterpriseEncryption: TKIP, AES

WLAN operating frequency For 2.4 GHz band: 2412 MHz ~ 2472 MHzFor 5.0 GHz band: 5180 MHz ~ 5320 MHz 5500 MHz ~ 5700 MHz

WLAN modulation Modulation technology: DSSS, OFDMModulation type: CCK, DQPSK, DBPSK for DSSS, 64QAM, 16QAM, QPSK, BPSK for OFDM

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Device Identification Module (DIM) technical specifications

DIMs do not require an external power supply and use standard DB9 and RJ45 connections. The Device ID Module is a medical grade product compliant with IEC 60601-1 requirements.

WLAN EIRP (Equivalent Isotropically Radiated Power)

For 2.4 GHZ: 18.59dBMFor 5.18 ~ 5.32 GHz: 18.69dBmFor 5.50 ~ 5.70 GHz: 18.41dBm

Wireless range 10-20 meters, depending on Wi-Fi network configuration

RFID operating frequency 13.56MHz

RFID modulation ASK

RFID EIRP -31.92dBm

Cooling Passive cooling system (fanless)

Operating environment • Temperature: 0°C to +40°C (+32°F to +104°F)• Humidity: 10% to 95% RH non-condensing• Atmospheric pressure: 700 hPa to 1060 hPa• Altitude: -100 m to 2000 m (-330 feet to 6560 feet)

Transport and storage environment

• Temperature: -20°C to +60°C (-4°F to +140°F)• Humidity: 0% to 95% RH non-condensing• Atmospheric pressure: 500 hPa to 1060 hPa

Device ID Module P/N B1-DIM-CT-01

Features • Provides Automatic Device Identification• DB9 Serial Port Input• RJ45 Serial Port Output• Powered from the SmartLinx Neuron, Terminal Server, or

DTS and RTS lines

Dimensions • Length: 69 mm (2.7 inches) • Width: 38 mm (1.5 inches) • Height: 22 mm (0.9 inches) • Weight: 50 grams (1.76 ounces)

Power requirements • +/- 6V output voltage• 3 to 8 milliamp power consumption

SmartLinx Neuron Part Number: DC-NU2-UMPC

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Regulatory Information

Explanation of Device and Packaging Symbols

Temperature • Operating: 0° C - 55° C (32° F to 130° F) • Storage: -30° C to +85° C (-22° F to +185° F)

Relative humidity • Operating: 0 to 99% non-condensing• Storage: 0 to 99% non-condensing

Atmospheric pressure • Operating: 700 hPa to 1060 hPa• Storage: 500 hPa to 1060 hPa

Certifications • EN60601-1, EN60601-1-2• CE Marking, RoHS-compliant

Symbol Description

Read the operating instructions before using the medical device.

Lot number

Quantity

Product part number

Product serial number

Product revision

Gross weight

Net weight

Temperature limitation for transport and storage

Device ID Module P/N B1-DIM-CT-01

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Air pressure limitation for transport and storage

Shelf-life of SmartLinx Neuron’s battery (with date three months after manufacture)

Manufactured date

Manufactured for

Do not use if package is damaged

Fire hazard

Relative humidity (non-condensing) for transport and storage

Ethernet MAC address

Ethernet

Wi-Fi

Wi-Fi MAC address

Caution: consult accompanying documents before using

Power symbol

Non-ionizing radiation

Compliance with FCC Regulations

Symbol Description

2017-06

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Safety and Regulatory Compliance

EN/IECSmartLinx Neuron complies with EN/IEC 60601-1 and EN/IEC 60601-1-2.

• Data Integrity: SmartLinx Neuron does not compromise the data coming from the medical device. This does not include data not being delivered or delays in data delivery.

• Medical Device Integrity: SmartLinx Neuron does not compromise the operation of the connected medical devices.

Compliance with European directives

Class 2 radio equipment

Rx Only Caution: United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner

Separate collection for electrical and electronic waste (WEEE directive and Battery directive)

Class II equipment

Direct current (DC)

USB connection

Serial connection

Input power

Recycling

Recognized component

Conforms to ANSI/AAMI ES 60601-1 StandardCertified to CAN/CSA Standard C22.2 No. 60601-1

Australian compliance mark

Symbol Description

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Federal Communications CommissionSmartLinx Neuron complies with Part 15 of the FCC Rules. Operation is subject to two conditions:

• This device may not cause harmful interference.• This device must accept any interference received, including interference that may cause undesired

operation.

Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

Note: For operation within 5.15 ~ 5.25GHz / 5.47 ~5.725GHz frequency range, SmartLinx Neuron 2 is restricted to indoor environment. The band from 5600-5650 MHz will be disabled by the software during the manufacturing and cannot be changed by the end user. This device meets all the other requirements specified in Part 15E, Section 15.407 of the FCC Rules.

Radiation Exposure Statement

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20 cm between the radiator and your body.

Note: The country code selection is for non-US model only and is not available on all US models. Per FCC regulation, all Wi-Fi products marketed in the USA must fixed to US-operation channels only.

CE DeclarationThe SmartLinx Neurons are class I devices that comply with the requirement of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices and carry CE-marking accordingly.

The SmartLinx Neuron complies with essential requirements and other relevant provisions of the Council Directive 1999/5/EC of March 9, 1999 concerning radio equipment and telecommunications terminal equipment and carry CE-marking accordingly.

This equipment may be operated in:

Caution: Capsule is not responsible for any radio or television interference caused by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment.

FCC Caution:Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment.This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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Country

Certain countries have specific restrictions for, or prohibitions on devices that operate in the 5 GHz band. Specifically in certain European countries, for example, some frequencies should be restricted to indoor use. You are advised to respect local requirements.

For a copy of the full R&TTE Declaration of Conformity, contact your Capsule Technologie representative. (For contact details, refer to “Distribution and Service” on page 8 of this manual.)

The Device ID Module (DIM) complies with the requirement of the Council Directives 2006/95/EC of December 12, 2006 concerning electrical equipment designed for use within certain voltage limits and 2004/108/EC of December 15, 2004 concerning electromagnetic compatibility.

Batteries in the SmartLinx Neuron are not based on mercury, lead or cadmium technologies. The batteries used in this product are in compliance with the Council Directive 2006/66/EC.

Chromium, lead, mercury, or cadmium are not intentionally added to packaging materials and are not present in a cumulative concentration greater than 100 ppm as incidental impurities. No halogenated plastics or polymers are used for packaging material. Packaging is compliant with the Council Directive 94/62/EC.

Industry Canada statementThis device complies with RSS-210 of the Industry Canada Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

AustriaBelgiumCyprusCzech RepublicCroatiaDenmarkEstoniaFinlandFranceGermanyGreece

HungaryIrelandItalyLatviaLithuaniaLuxembourgMaltaNetherlandsPolandPortugalSlovakia

SloveniaSpainSwedenUnited KingdomIcelandLiechtensteinNorwaySwitzerlandBulgariaRomaniaTurkey

Caution:(i) the device for operation in the band 5150-5250 MHz is only for indoor use to reduce the

potential for harmful interference to co-channel mobile satellite systems;(ii) the maximum antenna gain permitted for devices in the bands 5250-5350 MHz and 5470-

5725 MHz shall comply with the e.i.r.p. limit; and(iii) the maximum antenna gain permitted for devices in the band 5725-5825 MHz shall comply

with the e.i.r.p. limits specified for point-to-point and non point-to-point operation as appropriate.

(iv)Users should also be advised that high-power radars are allocated as primary users (i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices.

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FOR MOBILE DEVICE USAGE (>20cm/low power)Radiation Exposure Statement:

This equipment complies with IC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body.

RoHS and WEEE ComplianceThe SmartLinx Neuron, and DIM do NOT contain any of the following substances (in concentrations exceeding legal threshold limits):

• Lead• Mercury• Cadmium• Hexavalent Chromium• Polybrominated Biphenyls (PBB)• Polybrominated Diphenyl Ethers (PBDE)In the European Union, SmartLinx Neuron, DIM, batteries, and cables should be collected separately and not disposed of with household waste. Refer to the next section on Recycling and the Environment for more details.

Recycling and the Environment

Improper disposal of IT equipment can have a negative impact on health and the environment. The SmartLinx Neuron, DIM, batteries, and serial cables should be deposited at an appropriate facility to enable recovery and recycling. Packaging and manuals can also be recycled according to your local recycling scheme.

Technical Information [Chapter 5]